FDA 510(k)

OBS Electrosurgical Generator (Model: OBS-350A)

N.º K: K162034 · 2017-01-30

Fecha de decisión2017-01-30

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

OBS Electrosurgical Generator (Model: OBS-350A) is the device name listed in this FDA 510(k) record. The listed applicant is Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K162034. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OBS Electrosurgical Generator (Model: OBS-350A)?

OBS Electrosurgical Generator (Model: OBS-350A) is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Baisheng Medical Co., Ltd.. The 510(k) number is K162034.

When did OBS Electrosurgical Generator (Model: OBS-350A) receive FDA 510(k) clearance?

OBS Electrosurgical Generator (Model: OBS-350A) received FDA 510(k) clearance on 2017-01-30, under 510(k) number K162034.

Who is the listed applicant for OBS Electrosurgical Generator (Model: OBS-350A)?

The FDA 510(k) record lists Baisheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBS Electrosurgical Generator (Model: OBS-350A)?

The FDA product code for OBS Electrosurgical Generator (Model: OBS-350A) is GEI.

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Otros registros que enlistan a Baisheng Medical Co., Ltd. como solicitante

K250841Electrotherapy Electrodes K251235Electrosurgical Pads K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 K221815Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)

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Fuente oficial

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